Clinical Trial: Using Ultrasound Elastography to Predict Development of SOS

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Using Ultrasound Elastography to Predict Development of Sinusoidal Obstruction Syndrome

Brief Summary:

Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease.

Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.


Detailed Summary:

This is a single site prospective cohort study that will compare ultrasound elastography to traditional ultrasound parameters in bone marrow transplant patients who are at risk for development of SOS.

  • Primary objective: compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for detecting SOS in BMT patients.
  • Secondary objectives: 1. compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for classifying SOS in BMT patients. 2. compare sensitivity and specificity of traditional ultrasound parameters and ultrasound elastography of the liver for predicting death in BMT patients with SOS (defined as death within 100 days of transplant).
  • The validity and reliability of the primary and secondary measures when available. The validity of the measures will be determined by comparing to clinical gold standards of the diagnosis and classification of SOS

Data Collection Procedures

  • Candidates for the study will be identified by the Hematology Oncology service when they are admitted for bone marrow transplant.
  • A member of the study team will consent that patient and/or their parents once the patient has been identified.
  • If the patient consents to the study, an initial limited abdominal ultrasound with Doppler and shear wave elastography will be performed less than one month prior to bone marrow transplant. Demographic and clinical variables will be collected from the chart at the time of initial ultrasound and after date of discharge. Lab value variables will be col
    Sponsor: Children's Mercy Hospital Kansas City

    Current Primary Outcome: Presence or absence of SOS [ Time Frame: within 100 days of bone marrow transplant ]

    clinical determination by provider


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Severity of SOS [ Time Frame: within 100 days of bone marrow transplant ]

    death as noted in medical record


    Original Secondary Outcome: Same as current

    Information By: Children's Mercy Hospital Kansas City

    Dates:
    Date Received: June 25, 2015
    Date Started: August 2015
    Date Completion: December 2017
    Last Updated: June 25, 2015
    Last Verified: June 2015